Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary PCI
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 536
- 试验地点
- 1
- 主要终点
- TIMI flow grade
研究概览
简要总结
To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion in subjects with STEMI who underwent primary PCI
详细描述
This is a prospective, randomized, double-blind and controlled study.536 subjects of STEMI who underwent primary PCI within the first 12 hours will be enrolled.all patients were assigned to receive 300mg of asprin and ≥300mg of clopidogrel as loading dose,and following 100mg and 75mg once daily respectively.Patients were assigned to receive Salvianolate injection or 0.9% sodium chloride injection in catherter room setting,and following similar medicine once daily respectively for 7 days.Myocardial circulation perfusion will be checked with mmediate coronary angiography parameters,ECG,echocardiographic，CK-MB.The major adverse cardiovascular events will be observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent must be obtained prior to any study procedure.
- •Age>18 years.
- •Subjects of STEMI who underwent primary PCI within the first 12 hours.
排除标准
- •Allergic to Salvianolate injection
- •Mechanical complications
- •History of severe renal or hepatic insufficiency
- •Pregnant or breastfeeding women
- •Pool compliance,greater risks result from the study
研究组 & 干预措施
Experimental group
Patients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline
干预措施: Salvianolate injection (Drug)
Control group
Patients will be assigned to receive 100ml of normal saline
干预措施: Normal saline (Drug)
结局指标
主要结局
TIMI flow grade
时间窗: an average of 2 hours
Use TIMI flow grade to evaluate myocardial circulation perfusion
TIMI myocardial perfusion grade
时间窗: an average of 2 hours
Use TIMI myocardial perfusion grade to evaluate myocardial circulation perfusion
次要结局
- ST-segment resolution(up to 90 minutes)
- myocardial contrast echocardiograph(up to 7 days)
- creatine kinase isoenzyme(up to 48 hours)
- major adverse cardiovascular events(an average of 30 days)